Hiring: Vice President, Quality Assurance and Regulatory Affairs - Sarnova - Clearwater, FL Company: Sarnova Location: Clearwater, FL Job Posted Time: 2026-09-10 14:49:25 Employment Type: Contract Target Skills & Keywords : Quality Assurance, Regulatory Compliance, Revenue Cycle Management, Risk Management, Stakeholder Management About the job Experience: •15+ years of combined experience in quality assurance and regulatory affairs within the medical device or other regulated manufacturing environments •7+ years of progressive leadership experience leading quality and regulatory functions Required Skills: •Lead the enterprise Quality Assurance and Regulatory Affairs function, ensuring quality, and patient safety support business objectives and growth. •Develop, implement, and maintain an effective Quality Management System (QMS) aligned with FDA, ISO 13485, MDSAP, and other applicable regulatory requirements. •Serve as Sarnova’s primary quality and regulatory representative with regulators, auditors, customers, suppliers, and strategic partners. •Lead manufacturing quality programs, including production controls, process validation, CAPA, complaint handling, supplier quality, and inspection processes. •Develop and execute regulatory strategies for product approvals, registrations, market access, labeling compliance, and lifecycle management. •Partner with Product Development, Operations, Supply Chain, Marketing, Commercial, Sustainability and Legal teams to integrate quality and regulatory requirements throughout the product lifecycle. •Oversee design quality, design controls, risk management, verification and validation activities, and product transfer to manufacturing. •Direct post-market surveillance activities, including complaints, adverse event reporting, field actions, recalls, and product risk monitoring. Qualifications: •Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related technical discipline required; advanced degree preferred Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!